(331 days)
Not Found
No
The summary describes a laser system and its components, focusing on its physical characteristics and intended surgical uses. There is no mention of AI, ML, image processing, or data-driven decision-making within the device description or performance studies.
Yes
The device is intended for surgical procedures, including ablation, vaporization, and coagulation of soft tissue, which directly treats medical conditions.
No
The device description and intended use clearly state that the MultiPulse HoPLUS Laser system is for surgical procedures involving tissue incision, excision, resection, ablation, vaporization, coagulation, and haemostasis. These are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines a physical laser system with hardware components (laser, control panel, foot switch, fibers) and mentions hardware verification and validation. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for direct interaction with soft tissue in various medical specialties. This is a therapeutic and surgical device, not a diagnostic one.
- Device Description: The description details a laser system and fiber optic delivery system designed to emit laser radiation for surgical procedures. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are designed to detect, measure, or otherwise assess substances or characteristics in biological samples to aid in diagnosis, monitoring, or screening.
Therefore, the MultiPulse HoPLUS Laser system is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The MultiPulse HoPLUS Laser system and its fiber optic delivery system is a laser Class IV, pulsed, solid state Holmium-YAG, which emits laser radiation with a wavelength of approximately 2100 nm with a pulse with between 150-1700 microseconds. The laser power up to 140 Watts is transmitted to the tissue through different optical fibers.
The laser system consists of: Laser system including control panel (user interface) Foot switch A variety of application fibers and accessories
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethral, Bladder Neck, Bladder, Urethral, Ureteral, Prostate, External genitalia, Urinary tract (including kidney), Gall Bladder, Biliary/Bile duct, Joints (excluding spine), Cervical Disc, L4-5 and L5-SI lumbar discs, Thoracic Disc, Pulmonary tissue, Gynecological soft tissue, Endonasal / sinus, Skin, Subcutaneous tissue, Internal organs.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Data: Verification and Validation activities. These activities comprises the verification and validation of the software, the verification of the device, the verification of the fiber, the verification of the laser, an Investigation Report and the Final Test Report. These investigations lead to the conclusion, that the device is as safe and effective as the predicates and no additional risks occur.
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird with three human profiles incorporated into its design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2017
Asclepion Laser Technologies Gmbh Antje Katzer RA Manager Bruesseler Str. 10 Jena, 07747 DE
Re: K161257
Trade/Device Name: MultiPulse HoPlus Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: October 4, 2016 Received: October 6, 2016
Dear Antje Katzer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ndications for Use
Form Approved: OMB No. 0810-0120 Expiration Date: January 31, 2017 See PPRA Statement below
510(k) Number (if known
עוד מערב העיר המשפט המערכת המערכת המערכת המערכת המשפט המשפעיי שלו המע
Device Name
MultiPulse HoPLUS
Indications for Use (Describe
A Suns parsons, Discopers, Authouses, CAT, Democology, Partic Survey and County and rand see of vegation of visurily, subally solor in seu in our in our in oussit for to sizersomen and and institus in the include in consistences in interest of issues pur indossoneder unde guisu Typical Applications: saupsond leajans ni asu 100 bayar ya vilab sites and mais tress 1988 1998 1991 117 100 100
Urology
Building is and but notision, excition, excition, solation, solution, cossultation and personalism and personalisment Urethral Strictures
- Bladder Neck Incisions (BNI)
- Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Turno
- Ablation of Benign Prostatic Hypertrophy (BHP)
- Transurethral incision of the prostate (TUIP)
- Holmium Laser Resection of the Prostate (HoLRP
- Holmium Laser Enucleation of the Prostate (HoL
- Holmiurm laser Ablation of the Prostate (HoLAP
- Condylomas
- Lesions of external genitalia
- ithotripsy and Percutaneous Urinary Lithotripsy
- ອາໄສເດ ແຫຼ່ງໄຂວ ໂອແມ່ນປ່ວຕ່ ເປັນປະວັນທີ່ 15 ເຂົ້າອາ ປີຕາມສານ 10 ແບ່ນຂາກອານ 10 ແບບຊາກອານສຽງ ວ່າທ່ວຮອງປະຊາ
- monohydrate and calcium oxalate
- dehydrate stones.
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hemostasis including:
- Appendectomy
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- Biopsy
- Gall Bladder calculi
- Biliary/Bile duct calculi
- Olcers
- Gastric ulcers
- Duodenal ulcers
- Non Bleeding Ulcers
- Pancreatitis
Cholecystectomy
FORM FDA 3881 (8114
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Telangiectasias
Colorectal cancer
Beingin and Malignant Neoplasma · Angiodysplas
- Hemorrhoids
3
- · Telangiectasias of the Osler-Weber-Renu disease
- Vascular Malformation
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
- Mallory-Weisss tear
- Gastric Erosions
Arthroscopy
joints of the body, excluding the spine but including: a but in all (sussi) suouisely me for to the not the most of the more in and the sure single of the
- Ligament and tendom Release
- Contouring and sculpting of articular surfaces
- Capsulectorny in the Knee
- Chondreoplasty in the Knee
- Debridement of inflamed synovial tissue
- Chondromalacia Ablation
- Chondromalacia and tears
- Plica Removal
- Meniscectorny
- Loose Body Debridement
- Lateral retineacular release
- Abinal of soft, cating suisent lamining in suise Spinst Surgery including
- Percutaneous Cervical Disc Decompression/Discectorny Percursus Laser Disc Decompression of the L-F- and L-F-S and under discs, including Formingly
- Percutaneous Thoracic Disc Decompression/Discectory
Pulmonary
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ENT
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- Endonasal/sinus Surgery
- Partial turbinectomy
- Polypectomy
- Dacryocystorhinostom
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- Ethmoidectorny
- · Maxillary antrostomy
- Functional endoscopic sinus surgery
Dermatology and Plastic Surgery
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- Basal Cell Carcinomas
- Lesions of skin and subcutaneous tiss
- Skin tags
FORM FDA 3881 (8/14)
4
· Plantar warts
- Lesions of skin and subcutancous tissue
- Port Wine Stains
- · Papillomas
General Surgery
hemostasis) including: and and
- · Appendectorny
- Skin incision
- Excision of external lessions
- Complete or partial resection of internal organs, turnors and lesion
- Biopsy
Type of Use (Select one or both, as applicable)
A Presscription Use (Part 21 CFR 801 Subgation
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5
Image /page/5/Picture/0 description: The image contains the logo for Asclepion Laser Technologies. The word "Asclepion" is written in a dark gray sans-serif font. Below it, the words "Laser Technologies" are written in a smaller, similar font. To the right of the word "Asclepion" is a cluster of dark blue circles of varying sizes, arranged in a pattern that suggests a network or constellation.
Asclepion Laser Technologies GmbH · Brüsseler Str. 10 · 07747 Jena · Germany
SPECIAL 510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH MultiPulse HoPlus
This Special 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MultiPulse HoPLUS is submitted in accordance with the requirements of 21 CFR 807.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.
| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbH
Bruesseler Str. 10
07747 Jena, Germany |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mrs. Antje Katzer
Product Management and
International Regulatory Affairs |
| Phone: | +49 3641 77 00 309 |
| Fax: | +49 3641 77 00 302 |
| e-mail: | antje.katzer@asclepion.com |
| Preparation Date: | March 29, 2017 |
| Device Name: | MultiPulse HoPLUS |
| Common Name: | Surgical Holmium-Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in
dermatology
GEX
21 CFR 878.4810 |
| Equivalent Devices: | MultiPulse HoPLUS K131987 Asclepion Laser Technologies
Lumenis Pulse 120 K140388 Lumenis |
| Device Description: | The MultiPulse HoPLUS Laser system and its fiber optic delivery
system is a laser Class IV, pulsed, solid state Holmium-YAG, which
emits laser radiation with a wavelength of approximately 2100 nm with
a pulse with between 150-1700 microseconds. The laser power up to
140 Watts is transmitted to the tissue through different optical fibers. |
6
The laser system consists of: Laser system including control panel (user interface) Foot switch A variety of application fibers and accessories Intended Use: The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Urethral Strictures
Bladder Neck Incisions (BNI)
Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors
- Ablation of Benign Prostatic Hypertrophy (BHP)
Transurethral incision of the prostate (TUIP)
Holmium Laser Resection of the Prostrate (HoLRP)
Holmium Laser Enucleation of the Prostate (HoLEP)
Holmium laser Ablation of the Prostate (HoLAP)
Condylomas
Lesions of external genitalia
Lithotripsy and Percutaneous Urinary Lithotripsy
Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate
Dehydrate stones
Endoscopic fragmentation of kidney calculi
Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and hemostasis ) including:
| Appendectomy | Angiodysplasia |
|---|---|
| Polyps | Colorectal cancer |
| Biopsy | Telangiectasias |
| Gall Bladder calculi | Telangiectasias of the Osler-Weber-Renu disease |
| Biliary/Bile duct calculi | Vascular Malformation |
| Ulcers | Gastritis |
| Gastric ulcers | Esophagitis |
| Duodenal ulcers | Esophageal ulcers |
| Non Bleeding Ulcers | Varices |
| Pancreatitis | Colitis |
| Hemorrhoids | Mallory-Weiss tear |
| Cholecystectomy | Gastric Erosions |
| Benign and Malignant Neoplasma |
7
Arthroscopy / Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including: Ligament and tendon Release Contouring and sculpting of articular surfaces Capsulectomy in the knee Chondreoplasty in the knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal Meniscectomy Loose Body Debridement Lateral retineacular release Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-SI lumbar discs, including Forminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy
Pulmonary
Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue)
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue
8
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including: Endonasal / sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal sinustomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery
Dermatology and Plastic Surgery Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas General Surgery Open, laparoscopic and endoscopic surgery (incision, excision, ablation, vaporization,
coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete or partial resection of internal organs, tumors and lesions Biopsy
9
Summary of Technical Characteristics
| Proposed Modified Device | Un-Modified Predicate Device | Un-Modified Predicate Device | |
|---|---|---|---|
| Name | |||
| 510(k) | MultiPulse HoPLUS | ||
| Model 1911 | Multipulse Holmium Plus | ||
| Model 1910 | |||
| K131987 | Lumenis Pulse 120H | ||
| K140388 | |||
| Indications | Incision, excision, resection, | ||
| ablation, vaporisation, | |||
| coagulation and hemostasis | |||
| in medical specialties | Incision, excision, resection, | ||
| ablation, vaporisation, | |||
| coagulation and hemostasis in | |||
| medical specialties | Incision, excision, vaporization, | ||
| ablation and coagulation in | |||
| medical specialties | |||
| Device Type | Ho :YAG | Ho :YAG | Ho :YAG |
| Delivery | Different flexible | ||
| Quartz/Quartz fibers | |||
| Reusable and single use | Different flexible | ||
| Quartz/Quartz fibers | |||
| Reusable and single use | Different flexible Quartz/Quartz | ||
| fibers | |||
| Reusable and single use | |||
| Wavelength | 2100 nm | 2100 nm | 2100 nm |
| Average Power | 140 Watt | 110 Watt | 120 Watt |
| Energy range | 0,25 - 6 Joule | 0,3 - 3,5 Joule | 0,2 - 6 Joule |
| Pulse Duration | 150 - 1700 μs | 200-800 μs | adjustable |
| Repetition Rate | 5 - 100 Hz | Up to 75 Hz | 5 - 80 Hz |
| Power supply | 400 V 50 Hz/16 A 3-phase | 230V 50Hz/32A monophase | 230V 50Hz/ |